Adjustable prosthetic interfaces and related systems and methods

ABSTRACT

Prosthesis devices can include sockets having adjustable features. In one example, a socket includes one or more panels that can move outwardly or inwardly relative to a receptacle portion of the socket. The panels can be moved by tightening a tensioning line.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application No. 61/243,868, titled ADJUSTABLEPROSTHETIC INTERFACE AND METHODS, filed on Sep. 18, 2009, the entirecontents of which are hereby incorporated by reference herein.

TECHNICAL FIELD

The present disclosure relates to prosthetic devices and related systemsand methods.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain ofsuch illustrative embodiments that are depicted in the figures, inwhich:

FIG. 1 is a front perspective view of an embodiment of an adjustableprosthetic system that includes a socket and adjustable panels;

FIG. 2 is a rear perspective view of the adjustable prosthetic system ofFIG. 1;

FIG. 3 is a cross-sectional view of a portion of the adjustableprosthetic system of FIG. 1 taken along the view line 3-3 in FIG. 1;

FIG. 4 is a front perspective view of another embodiment of anadjustable prosthetic system that includes a socket and adjustablepanels;

FIG. 5 is a rear perspective view of the adjustable prosthetic system ofFIG. 4;

FIG. 6A is a schematic front view of another embodiment of an adjustableprosthetic system showing a routing pattern of a tensioning line;

FIG. 6B is a schematic front view of another embodiment of an adjustableprosthetic system showing another routing pattern of a tensioning line;

FIG. 7 is a front perspective view of an embodiment of a tighteningmechanism coupled with an embodiment of a tensioning line, wherein thetightening mechanism and the tensioning line are suitable for use withthe embodiment of an adjustable prosthetic system depicted in FIG. 1;

FIG. 8 is an exploded front perspective view of the tightening mechanismand the tensioning line of FIG. 7;

FIG. 9 is a rear perspective view of an embodiment of a knob portion ofthe tightening mechanism of FIG. 7;

FIG. 10 is an upper rear perspective view of the tightening mechanism ofFIG. 7;

FIG. 11 is a lower rear perspective view of the tightening mechanism ofFIG. 7;

FIG. 12 is an upper rear perspective view of an embodiment of a templatethat is shaped to resemble a portion of the tightening mechanism of FIG.7;

FIG. 13 is a lower rear perspective view of the template of FIG. 11;

FIG. 14A-14J are schematic plan views of various stages of anillustrative method for manufacturing an embodiment of an adjustablesocket;

FIG. 15 is perspective view of an embodiment of a kit that is configuredto be used in the manufacture of an adjustable socket;

FIG. 16 is a perspective view of an embodiment of a cap template that isconfigured to be coupled with a base portion of the tightening mechanismof FIG. 7;

FIG. 17 is a perspective view of another embodiment of a kit that isconfigured to be used in the creation of an adjustable socket;

FIG. 18 is a left side elevation view of another embodiment of anadjustable prosthetic system;

FIG. 19 is a front elevation view of the adjustable prosthetic system ofFIG. 18.

FIG. 20 is an enlarged partial rear elevation view of the adjustableprosthetic system of FIG. 18;

FIG. 21 is an enlarged partial front elevation view of the adjustableprosthetic system of FIG. 18;

FIG. 22 is a top plan view of the adjustable prosthetic system of FIG.18 showing the system in a first operational state;

FIG. 23 is another top plan view of the adjustable prosthetic system ofFIG. 18 showing the system in a second operational state;

FIG. 24 is a partial left side elevation view of another embodiment ofadjustable prosthetic system;

FIG. 25 is a partial rear elevation view of the adjustable prostheticsystem of FIG. 24;

FIG. 26 is a partial left side elevation view of another embodiment ofan adjustable prosthetic system;

FIG. 27 is a partial left side elevation view of another embodiment ofan adjustable prosthetic system;

FIG. 28 is a partial rear elevation view of the adjustable prostheticsystem of FIG. 27;

FIG. 29 is a partial front elevation view of the adjustable prostheticsystem of FIG. 27;

FIG. 30 is a front elevation view of another embodiment of an adjustableprosthetic system.

FIG. 30A is a cross-sectional view of a portion of the adjustableprosthetic system of FIG. 30;

FIG. 31 is a right side elevation view of the adjustable prostheticsystem of FIG. 30;

FIG. 32 is a left side elevation view of the adjustable prostheticsystem of FIG. 30;

FIG. 33 is a rear elevation view of the adjustable prosthetic system ofFIG. 30;

FIG. 34 is a top plan view of the adjustable prosthetic system of FIG.30;

FIG. 35 is a rear elevation view of the anatomy of a human left leg;

FIG. 36 is a right side elevation view of the anatomy of a human rightleg;

FIG. 37 is a schematic cross-sectional view of the human leg taken alongthe view line 37-37 in FIG. 35 and illustrating directions in whichforces are applied by the adjustable prosthetic system of FIG. 30;

FIG. 38 is a schematic side elevation view of a residuum of a human legwithin the adjustable prosthetic system of FIG. 30;

FIG. 39 is a front elevation view of another embodiment of an adjustableprosthetic system schematically showing an intended position of aportion of a femur therein;

FIG. 40 is a rear elevation view of the adjustable prosthetic system ofFIG. 40;

FIG. 41 is a right side elevation view of the adjustable prostheticsystem of FIG. 40;

FIG. 42 is a left side elevation view of the adjustable prostheticsystem of FIG. 40;

FIG. 43 is a schematic cross-sectional view of the human leg taken alongthe view line 43-43 in FIG. 36 and illustrating directions in whichforces are applied by the adjustable prosthetic system of FIG. 40

FIG. 44 is a perspective view of an embodiment of a kit that isconfigured to be used in the creation of an adjustable socket.

DETAILED DESCRIPTION

Various embodiments of prosthetic devices that are configured to beadjustable relative to a residual limb (or “residuum”) of an amputee aredescribed herein. An example of one such embodiment is depicted in FIGS.1 and 2, which is discussed in detail below. Related systems and methodsare also disclosed. In certain embodiments, a prosthetic device includesa socket that has adjustable portions. The adjustable portions can beconfigured to move relative to a substantially rigid portion of thesocket that substantially maintains its shape during movement of theadjustable portions. Accordingly, in some embodiments, the socketsubstantially maintains its general shape, while only portions thereofare moved so as to contact specific regions of the residuum. Suchsystems can enhance the comfort of a wearer of the prosthetic device,and can otherwise improve the operation of the device, as compared withstandard prosthetic devices. Other features and advantages of thevarious embodiments described herein will be evident from the disclosurethat follows.

For the sake of convenience, much of the following disclosure isdirected to prosthetic devices that are configured for use with residualportions of an amputated leg, such as a leg that has undergone atransfemoral (i.e., above-knee) or transtibial (i.e., below-knee)amputation. It should be appreciated that the disclosure is alsoapplicable to other prosthetic devices, such as those configured for usewith the residuum of an amputated arm (e.g., after an above-elbow orbelow-elbow amputation).

The use of transtibial prostheses by transtibial amputees is generallywell known. Transtibial prostheses can include a socket, a shank, and afoot-ankle system. A variety of sockets, shanks, and foot-ankle systemsare available, which can be combined in any suitable manner to produce atranstibial prosthesis that is tailored to meet the individual needs ofdifferent transtibial amputees. The socket generally acts as aninterface between the amputee and the prosthesis. The socket can beinstrumental in transferring the weight of a transtibial amputee to theground by the way of the prosthesis. The shank can transfer verticalloads (e.g., at least a portion of the weight of the amputee) to thefoot-ankle system, which interfaces with the ground.

The general use of a socket to fit a transtibial prosthesis to aresiduum is well known. Some sockets have total contact with theresiduum, and may contact the residuum substantially about a fullperiphery thereof. Other or further sockets can define four walls, andeach wall of a socket can have a specific function relative to theresiduum. The four walls can include an anterior wall, a posterior wall,a medial wall, and a lateral wall.

Whether the prosthesis is a transtibial or transfemoral prosthesis, oreven an upper limb prosthesis (such as for upper or lower arm amputees),the interface between the prosthesis and the person's residuum is ofgreat importance. The socket portion of the prosthesis typically definesthe primary interface between the prosthesis and the residuum. Severalfactors can be weighed in the design of a socket, including whether thesocket satisfactory transmits the desired load, provides satisfactorystability, provides efficient control for mobility, is easily fitted,and/or is comfortable.

The residuum typically changes size not only over months or years as theamputee's body ages or recovers from the initial amputation, but also ondaily basis, and even throughout a given day. The daily or short-termfluctuations in residuum size often are a result of water retention orloss. The more active an amputee is throughout the day, the greater thewater loss in the residuum may be. This change in size can have aneffect on the fit between the residuum and the prosthesis socket.Amputees often account for such a reduction in limb size by adding asock to the limb. Adding the sock often requires a person to remove anarticle of clothing, remove and then replace the prosthesis, and thenput back on the removed article of clothing. This process not only canbe time consuming, but it can also require a certain amount of privacy.In many instances, a number of socks (e.g., 3, 5, 10, or more) may beadded to the residuum throughout the day in order to maintain adequatefit between the residuum and socket for the amputee to avoid the painand discomfort that can result from an improper fit.

The addition of socks to the residuum can negatively affect a fitbetween the prosthesis and the residuum. As socks are added to theresiduum, a gap between the residuum and the socket in the lateraldirection may be filled, as desired, but the entire limb may alsoconcurrently change position relative to the socket in an axialdirection. This axial shift can displace the limb from specificallycontoured features of the socket that typically serve as the interfacebetween the socket and the residuum such that the complementary portionsof the residuum no longer correspond with their socket counterparts.Furthermore, an entirety of a residuum may not decrease in size as aresult of water retention or loss. Rather, size reduction may generallybe isolated to areas of soft tissue and muscle. Accordingly, addinglayers of socks over areas of bony anatomy that has not lost any volumecan increase pressure on those bony areas, thus creating pressure sores.Also, additional of one or more socks to a residuum can becomeuncomfortably hot for the wearer due to the insulating properties of thesocks, and may lead to perspiration that can result in a painful orineffective fit. One or more of the drawbacks or limitations of knownprosthetic devices and systems and/or methods for their use, such asthose just described, may advantageously be reduced or eliminated byembodiments disclosed herein.

FIGS. 1-3 illustrate an embodiment of an adjustable prosthetic system100. As shown in FIGS. 1 and 2, the system 100 includes a prostheticdevice 102, distal and proximal tensioning lines 104, 105, distal andproximal guide members 106, 107, and distal and proximal tighteningmechanisms 108, 109. In the illustrated embodiment, the prostheticdevice 102 is configured as a substitute for a portion of a right leg ofan amputee. The prosthetic device 102 includes a socket 110, a supportor pylon 112, and an ankle-foot structure 114. As described furtherbelow, the socket 110 can be configured to receive a residuum of a legtherein. The pylon and/or the ankle-foot structure may be termed moregenerally as a prosthetic extremity 115, such that the socket 110 can besaid to serve as an interface between the residuum and the prostheticextremity 115. Any suitable arrangement of the prosthetic extremity 115is possible.

The socket 110 includes a receptacle region 120, also referred thereherein simply as a receptacle, and further includes a plurality ofpanels 122 a-122 f that are configured to move relative to thereceptacle 120. The socket 110 can be configured to provide a highamount of surface contact with the limb to achieve a close fittherewith, which can correlate with the high amount of comfort for theuser. In the illustrated embodiment, the receptacle 120 is shapedsubstantially as an elongated cup that is sized to receive the residuumof a transtibial amputation therein. The receptacle 120 defines anopening 124 at an upper end thereof and narrows toward a lower endthereof. The receptacle 120 can include a support attachment 126 towhich the pylon 112 is mounted.

The receptacle 120 can include four general sides, portions, or regions132, 134, 136, 138. As the receptacle 120 is configured for use with aright leg of an amputee, the right side may be referred to as a lateralregion 132, the left side may be referred to as a medial region 134, aforward side may be referred to as an anterior region 136, and arearward side may be referred to as a posterior region 138.

The receptacle 120 can define a cavity 140 into which the residuum canbe received. The receptacle 120 can be substantially rigid so as tomaintain its shape or form when forces are applied thereto, whether fromthe residuum when it is positioned therein or from compressive forces atan exterior thereof. The term “substantially rigid” is sufficientlybroad to cover arrangements where the receptacle 120 is sufficientlyrigid, solid, or firm so as to undergo no change in shape orconfiguration due to stresses applied thereto by the residuum undernormal use (i.e., solid), as well as arrangements where the receptacle120 is very rigid, solid, or firm, but is resilient and may undergoslight, non-permanent deformations due to the standard stresses of use(i.e., flexibly firm).

The receptacle 120 can have a wall structure 142 that includes one ormore materials, and may include one or more laminated layers 144, 146(see FIG. 3). In various embodiments, one or more layers 144, 146 of thewall structure 142 of the receptacle 120 can include one or morehardened plastic resins (e.g., acrylic, epoxy, polyester). In other orfurther embodiments, one or more layers 144, 146 can comprise one ormore reinforcement textiles (e.g., fiberglass, nylon, carbon, Dacron®,Kevlar®). Any other suitable materials may be used.

In the illustrated embodiment, the receptacle 120 defines a series ofports 150 a-150 f that correspond with the panels 122 a-122 f. Inparticular, the ports 150 a-150 f are sized and shaped so as to permitthe panels 122 a-122 f to move freely therethrough. For one or more ofthe ports 150 a-150 f (e.g., the port 150 a), edges of the port 150 amay substantially define a plane, and the associated panel 122 a may beconfigured to move relative to the port 150 a in a direction that isnormal to the plane. More generally, the panels 122 a-122 f can beconfigured to move outwardly or inwardly relative to the cavity 140. Thepanels 122 a-122 f may also be termed to move in a radial direction, butthis does not necessarily imply that the panels 122 a-122 f move along aline that is directed through an axial center of the receptacle 120, nordoes it necessarily imply that a cross-sectional perimeter of thereceptacle 120 is circular. The illustrated panels 122 a-122 f are fullyseparated from the receptacle 120 and are able to move independently ofthe receptacle 120. The panels 122 a-122 f may be termed as freefloating.

In other embodiments, such as discussed below, the socket 110 caninclude panels that are connected to the receptacle 120, such as via ahinge. For example, an edge of a panel may be fixedly connected to thereceptacle 120, whereas other edges of the panel can be separate fromthe receptacle 120 so as to move freely relative thereto. In theillustrated embodiment, the panels 122 a-122 f can be moved relative tothe receptacle 120 substantially without changing a shape orconfiguration of the receptacle 120.

As shown in FIG. 3, the panel 122 may comprise the same material as thatof the receptacle 120. For example, at least a portion of the panel 122can be cut from the wall structure 142 in a manner such as discussedbelow. However, in other embodiments, the panels 122 may comprise one ormore materials that are different from those of which the receptacle 120is formed.

In the illustrated embodiment, each panel 122 a-122 f includes a pad 154at an interior thereof. The pad 154 can be configured to contact theresiduum (e.g., directly contact the residuum) or to apply pressure tothe residuum. Accordingly, the panels 122 a-122 f may also be referredto herein as pressure members. The pad 154 can have a thickness suchthat a total thickness of the panel 122 is thicker than the portion ofthe receptacle 120 that surrounds the panel 122. The pad 154 cancomprise any suitable material. In some applications, the pad 154 may bedeformable and resilient, and the pad may have any suitable flexibilityor durometer properties.

Due to a thickness of a panel 122, the panel can be forced outwardlyrelative to the receptacle 120 when the residuum (when it is in arelatively large state), is positioned within the cavity 140 of thereceptacle 120. For example, in the embodiment shown in FIG. 3, the pad154 extends into the cavity 140 when an outer surface of the panel 122is flush with an outer surface of the receptacle 120. Accordingly, thepad 154 can be moved outwardly to bring an inner surface of the pad 154into alignment with an inner surface of the receptacle 120 and so as topermit the residuum to fill the cavity 140. As the residuum decreases involume over time, the panel 122 can be pulled inwardly so as to applypressure to the residuum, or so as to maintain a desired pressure on theresiduum, and thus achieve or maintain a desired fit therewith.

Any suitable number and arrangement of the panels 122 a-122 f ispossible. For example, in various embodiments, the socket 110 cancomprise one or more, two or more, three or more, four or more, five ormore, or even ten, fifteen, or twenty or more panels. As discussedfurther below, the position, size, and/or shape of each panel may bespecific to a particular residuum for which the socket 110 has beenmanufactured. Moreover, one or more of the panels 122 a-122 f may beconfigured to contact a portion of the residuum that is more prone tochange in size, as compared with other portions of the residuum. In theillustrated embodiment, the panels 122 a-122 f are sized and shaped tointeract with specific portions of the residuum as follows: the panel122 a is configured to apply pressure to the gastrocnemius muscle andthe soleus muscle, or more generally, to a posterior muscle compartment;the panel 122 b is configured to apply pressure to a posterior medialaspect of the tibia, or more generally, to a medial region of the tibia;the panel 122 c is configured to apply pressure to an anterior medialaspect of the tibia; the panel 122 d is configured to apply pressure tothe interosseous membrane; the panel 122 e is configured to applypressure to a patellar tendon region; and the panel 122 f is configuredto apply pressure to a medial patellar tendon region. Other arrangementsare also possible.

In the illustrated embodiment, the panels 122 a-122 f are arrangedgenerally in either a lower or distal zone 156 (panels 122 a-122 d) oran upper or proximal zone 158 (panels 122 e, 122 f). The panels of thedistal zone 156 are all coupled with the distal tensioning line 104, andthe panels of the proximal zone 158 are both coupled with the proximaltensioning line 105. Each zone of panels is thus interconnected. Statedotherwise, each set of panels is able to move inwardly in tandem and/orapply an increased amount of pressure on the residuum in tandem.

The tensioning lines 104, 105 can comprise any suitable arrangement,such as, for example, a wire, cable, or the like (e.g., a lace), and maybe relatively flexible or pliant in transverse direction but relativelyinextensible in a longitudinal direction. The tensioning lines 104, 105can comprise any suitable material, such as, for example, metal,polyester, or Spectra.

The tensioning lines 104, 105 can be positioned within the guides 106,107, which can define separate guide paths 160, 161. The guides 106, 107can be configured to protect the wall structure 142 of the receptacle120 from wearing due to friction from the tensioning lines 104, 105. Theguides 106, 107 can also protect the tensioning lines 104, 105 fromundue wear. In some embodiments, a guide 106, 107 comprises a tube ofany suitable polymeric material (e.g., nylon) through which thecorresponding tensioning line 104, 105 is threaded. As shown in FIG. 3,in some embodiments, the guides 106, 107 can extend through an interiorof a panel 122. For example, the guide 107 may run substantiallyparallel to an outer surface of the panel 122 f. In the illustratedembodiment, the guides 106, 107 are laminated between two layers of thepanel 122, and due to the lamination process employed, protrusions 163of the outer surface are present along a length of each guide path 160,161.

As discussed below, the guide paths 160, 161 can define any suitablecontour. In the illustrated embodiment, the distal guide path 160includes two horizontally directed portions that are joined at each endby a substantially C-shaped reversal (not shown). One of the reversalsis located within the panel 122 a, whereas the other is located withinthe lateral region 124 of the receptacle 120. Each end of the guide path160 terminates at an opposing side of the tightening mechanism 108.Similarly, the proximal guide path 161 includes two horizontallydirected portions. At one end, the horizontal portions are joined by aC-shaped reversal, whereas at the other end (shown in FIG. 2), the guidepath 161 terminates at the proximal tightening mechanism 109. In theillustrated embodiment, each end of the guide path 160 terminates at anopposing end of the tightening mechanism 109. Other patterns for theguide paths 160, 161 are also possible. For example, whereas in theillustrated embodiments the guide paths 160, 161 never cross overthemselves and/or each other, in other embodiments they do.

In the illustrated embodiment, each of the guide paths 160, 161 makestwo passes through the panels in their respective zones. Moreover, dueto the pattern of or course followed by the guide paths 160, 161,separate portions of each of the tensioning lines 104, 105 move througheach of the panels 122 a-122 d and 122 e, 122 f, respectively, inopposite directions. The upper and lower passes of the guide paths 160,161 through the panels allow the tensioning lines 104, 105 to provide abalanced or evenly distributed inward force to the panels 122 a-122 f,which can reduce torquing of the panels. Other arrangements are alsopossible. For example, in some embodiments, a tensioning line can passthrough a panel only once, such as through its center. In otherembodiments, a tensioning line can pass through a panel two or more,three or more, or four or more times.

As shown in FIG. 2, the tensioning lines 104, 105 can be connected tothe tightening members 108, 109, each of which can be configured toincrease or decrease a tension in the tensioning lines 104, 105,respectively. With reference only to the distal tightening member 108for the sake of convenience, the tightening member can include anactuator 170. In some embodiments, the actuator 170 can be used toselectively and/or incrementally increase the tension in the tensioningline 104. In other or further embodiments, the actuator 170 can be usedto selectively and/or incrementally decrease the tension in thetensioning line 104. In the illustrated example, the tightening member108 comprises a ratcheting device 300, which is described below. Theproximal tightening member 109 can be similar to the distal tighteningmember 108, but may be smaller in some embodiments.

In the illustrated embodiment, the tightening member 108 is fixedlyattached to the panel 122 a, and thus is configured to move relative tothe receptacle 120. In other embodiments, such as that illustrated inFIGS. 4 and 5, the tightening member 108 can be fixed relative to thereceptacle 120. In either case, actuating the tightening member 108 cancause the panels 122 a-122 d to move radially inward. For example in theillustrated embodiment, actuating the tightening member 108 can draw aportion of the tensioning line 104 into the tightening member 108 so asto constrict a perimeter defined by the tensioning line 104. Suchconstriction can urge the panels 122 a-122 d inwardly.

FIGS. 4 and 5 illustrate another embodiment of an adjustable prostheticsystem 200, which can resemble the adjustable prosthetic system 200described above in certain respects. Accordingly, like features aredesignated with like reference numerals, with the leading digitsincremented to “2.” Relevant disclosure set forth above regardingsimilarly identified features thus may not be repeated hereafter.Moreover, specific features of the adjustable prosthetic system 200 maynot be shown or identified by a reference numeral in the drawings orspecifically discussed in the written description that follows. However,such features may clearly be the same, or substantially the same, asfeatures depicted in other embodiments and/or described with respect tosuch embodiments. Accordingly, the relevant descriptions of suchfeatures apply equally to the features of the adjustable prostheticsystem 200. Any suitable combination of the features and variations ofthe same described with respect to the adjustable prosthetic system 100can be employed with the adjustable prosthetic system 200, and viceversa. This pattern of disclosure applies equally to further embodimentsdepicted in subsequent figures and described hereafter.

The adjustable prosthetic system 200 can include a socket 210 thatincludes a receptacle 220 and a plurality of panels 222 b-222 f. Thepanels 222 b-222 d are positioned within a lower zone 256, and thepanels 222 e, 222 f are positioned within an upper zone 258. The system200 further comprises a distal tensioning line 204 and a distal guide206 that pass through the panels 222 b-222 d, and also comprises anproximal tensioning line 205 and proximal guide 207 that pass throughthe panels 222 e, 222 f. The lower tensioning line 204 is connected to alower tightening member 208, and the upper tensioning line 205 isconnected to an upper tightening member 209. Each of the upper and lowertightening members 209, 208 is fixedly secured to the receptacle 220.Each of the tensioning lines 204, 205 follows a guide path 260, 261 thatresembles the guide paths 160, 161 described above. However, otherarrangements of the guide paths 260, 261 are possible.

FIGS. 6A and 6B schematically illustrate two additional patterns thatthe guide path 260 can take. In FIG. 6A, the guide path 260 proceedsfrom the tightening mechanism 208 through an upper end of the panel 222c, through a lower end of the panel 222 d, circles around the back ofthe receptacle 220, proceeds through a lower end of the panel 222 c,through an upper end of the panel 222 d, and then terminates at anopposite side of the tightening mechanism 208. As can be seen, the guidepath 260 crosses over itself within the receptacle 220 at a positionbetween the panels 222 c, 222 d.

In FIG. 6B, the guide path 260 proceeds from the tightening mechanism208 through an upper end of the panel 222 c, defines a C-shaped turnwithin the receptacle 220 and then proceeds through a lower end of thepanel 222 c, circles around the back of the receptacle 220, proceedsthrough a lower end of the panel 222 d, defines a C-shaped turn withinthe receptacle 220 and then proceeds through an upper end of the panel222 d, and then terminates at an opposite side of the tighteningmechanism 208. As can be seen, the guide path 260 does not cross overitself at any point.

As previously mentioned, the systems 100, 200 can be used with anysuitable tightening mechanism. An illustrative example of an embodimentof a suitable tightening mechanism is provided in FIGS. 7-11. Additionalillustrative tightening mechanisms are shown and described furtherbelow.

With reference to FIGS. 7-11, a ratcheting device 300 can include ahousing 310 and an actuator 311. In FIGS. 7 and 8, the ratcheting device300 is shown coupled with a tensioning line 304. The actuator 311 isoperable to selectively rotate in a first direction (e.g., clockwise) soas to gather the tensioning line 304 within the housing 310 when theactuator is in an engaged state, and is operable to permit a release oftension from the tensioning line 304 (whether full or partial) when theactuator is in a tension-release state.

The actuator 311 includes a knob 320 that has a plurality of pawls 322.As shown in FIG. 9, the knob 320 includes a gear 324 with teeth 326. Thehousing 310 includes a cover 314 and a base 312 that cooperate with eachother to secure a spool 340 therein. The cover 314 includes an upwardprotrusion 330 that has a plurality of teeth 332 that are configured toengage with the pawls 322 so as to permit the knob 320 to move in afirst direction relative thereto but to prevent movement in a seconddirection relative thereto. The cover 314 defines an opening 333 thatcan receive a portion of spool 340 so as to maintain an alignmentthereof. The cover 314 further defines a resilient arm 334 that definesa tab 336 at an end thereof (see FIGS. 10 and 11).

The base 312 of the housing 310 defines a cavity 358 for receiving thespool 340. The base 312 defines two openings 360 through which thetensioning line 304 can enter the housing 310 so as to wrap around thespool 340. The spool 340 includes teeth 342 that are configured toengage with the teeth 326 of the knob 322 so as to rotate the spool 340.

The base 312 of the housing 310 includes a base region 350 that isbordered by a flange 352 at an upper end thereof. The base 312 includesa resilient arm 354 that includes a tab 356 at an upper end thereof.

A post 380 can extend through the base region 350 of the base 312 andcan be secured to the knob 320 via a screw. A plate 390 can be attachedto the base 312 so as to prevent the post 380 from being removed fromthe base 312. The post includes a flange 382 (see FIGS. 8 and 11), andthe base 312 defines a resilient catch 362 (FIG. 10). When the knob 320is pushed downwardly, the flange 382 of the post 380 bypasses the catch362 and is held in place thereby. The knob 320, when in this position,is in an engaged or tightening state. When in this state, the pawls 322of the knob 320 are engaged with the teeth 332 of the protrusion 330 ofthe cover 314.

With sufficient force, the knob 320 can be pulled outwardly so as tomove the flange 382 of the post 380 upwardly past the catch 362. When inthis position, the knob 320 is in the tension-release state, as thepawls 322 no longer engage the teeth 332 and the teeth 326 of the gear324 of the knob 320 no longer engage the teeth 342 of the spool 340. Thespool is thus free to rotate in a direction opposite of that used totighten the tensioning line 304, and may do so, for example, untilsufficient tension is released for the rotation to terminate.

The ratcheting device 300 thus permits rotation of the knob 320 in asingle direction while limiting rotation of the knob 320 in the oppositerotation direction. Moreover, the ratcheting device 300 may allowsincremental adjustments feature to tension in the line 304. A largernumber of teeth 332 can allow for small increments of change in thetension. In various embodiments, the teeth can permit anywhere from 1 to30 degrees of rotation, which can result in a small amount of change intension in the tensioning line 304 with each step. Such capability ofapplying incremental amounts of tension in the tensioning line 304 maypermit a user to tighten portions of the sockets 110, 120 incrementally,as needed or as desired, as portions of the residuum change size.

FIGS. 12 and 13 illustrate an embodiment of a dummy or template 400 thatcan be used in a lamination procedure. The template 400 can be used toform a cavity dimensioned to receive and secure the housing 310 of theratcheting device 300. An outermost perimeter of the template can be thesame size as or larger than an outermost perimeter of the base region350 of the base 312 such that the cavity formed by the template within awall structure material is sufficiently large to receive the base region350 of the housing 310. The template 400 can further include featuresthat correspond with those of the housing 310. In particular, thetemplate 400 can define an upper ridge 456 and a lower protrusion 436that can correspond in shape and/or size with the tabs 356, 336 of thehousing, respectively.

The template 400 can define a channel 460 that can correspond in size tothe openings 360 of the housing 310. A position of the channel 460relative to the template 400 can correspond with a position of theopenings 300 relative to the housing 310. The channel 460 can extendthrough at least a portion of the template 400 from either side thereof.

The template 400 can comprise any suitable material, and may besubstantially rigid. The template 400 may be configured to readilyrelease from a hardened resin material. In some embodiments, thetemplate comprises a plastic, such as a thermoplastic (e.g., Delrin®).

FIGS. 14A-14J illustrate various stages of an illustrative method inwhich the template 400 can be used in the formation of a socket. Someportions of the procedures are known in the art, and thus will not bedescribed in detail. It is also noted that many different materials andprocedures are possible, and that the following discussion is merelyillustrative of examples of the same.

FIG. 14A illustrates placement of the template 400 and a guide 306 at adesired position during a lay-up procedure. Dried and hardened plastermold 502 that represents the residuum is covered with a barrier layer504 of flexible plastic or foam, such as a PVA bag. Another layer 506 ofplastic, such as a PVA bag is positioned over the layer 504. Theselayers are covered by one or more layers of fibers and/or fabric, suchas a carbon fiber layer 508. The template 400 may be attached to thelayup in any suitable manner, such as by an adhesive. The guide 306 isrouted about the plaster mold 502 in any desired guide path, such as,for example, those discussed above. Either end of the guide 306 isinserted deeply into the template 400 (i.e., into the channel 460). Theguide 306 can form a tight fit with the channel 460 so as to preventliquid resin from entering therein.

FIG. 14B shows that another layer 520 of one or more materials (e.g.,fabric and or fibers) may be provided over the template 400 and theguide 306 such that these items are sandwiched therebetween. Anotherbarrier layer 522 of plastic is provided over the layer 520.

FIG. 14C illustrates the introduction of liquid resin 524 about thetemplate 400 and the guide 306. The resin 524 can saturate the fabriclayers 508, 520, and can be constrained by the barrier layers 506, 522.

FIG. 14D shows the hardened or cured resin 522 and the barrier layers506, 522 removed. The template 400 and the guide 306 are thus positionedwithin a single laminated layer.

FIG. 14E shows a portion of the resin 522 removed from above thetemplate 400. The resin 522 can be removed in any suitable manner, suchas by sanding or grinding. Caution may be used to grind the resin downonly enough so as to expose the top surface of the template 400.

FIG. 14F shows a stage after removal of the template 400, which forms avoid or cavity 514 in the laminated wall structure. The guide 306remains on the original guide path that it defined during layup. Anupper recess 530 and a lower recess 532 of the cavity 514 are shown.These recesses 530, 532 have been formed by the upper ridge 456 and alower protrusion 436 of the template 400.

FIG. 14G shows the base 312 of the housing 310 inserted into the cavity514.

FIG. 14H shows another portion 540 of the laminated wall structure thatis spaced from the base 312. The wall structure is cut along a cut path544. The cut path 544 can have any desired pattern so as to form a panelof a desired shape. A gap 542 thus may be formed between the panelportion of the wall structure and a receptacle portion thereof. The cutpath 544 can extend through the guide 306 such that the guide is cutduring formation of the panel. Any suitable number of panels can be cutfrom other portions of the wall structure in the same manner.

In some embodiments, a substantially linear tool (not shown) may be usedto create the cut path 544. In some embodiments, care may be taken toensure that linear tool is oriented substantially perpendicular to asingle plane during creation of the gap 542, which may facilitatemovement of the panel relative to the surrounding region of thereceptacle.

FIG. 14I shows that the tensioning line 304 has been threaded throughthe entire guide 306. In particular, the line 304 has been threadedthrough the receptacle portion of the wall structure and also throughthe cut panel portion thereof.

FIG. 14J shows that the tensioning line 304 has been secured to thespool 340 and the housing cover 314 has been secured to the base 312.The ratcheting device 300 thus can be secured in place by insertion ofthe tabs 356, 336 into the recesses 530, 532. Additional and/or othermethods for securing the ratcheting device 300 also may be employed,such as the use of adhesives. The tensioning line 304 can be tightenedby rotation of the knob 320.

The foregoing method is an example of a single-lamination method. Inother methods, multiple laminations may be performed. For example, withreference to FIG. 14A, in some embodiments, the template 400 mayoriginally be secured to a first laminated layer, rather than tounlaminated materials. The template 400 can then form a cavity in asecond lamination layer into which the ratcheting device 300 isreceived. The foregoing methods may also be used at other positions of asocket in order to create multiple independent adjustment zones, suchas, for example, the distal and proximal zones 156, 158 discussed above.

FIG. 15 illustrates that a kit 600 may include materials that can beused in a lamination procedure, such as those just described. The kit600 can include any suitable combination of the ratcheting device 300,the template 400, an adhesive 602 which can be used in placement of thetemplate 400, the tensioning line 304, the guide 306, and instructions604. Additional items may also be included in the kit 600. For example,in some embodiments, a pad (not shown) that can be attached to an innersurface of a panel that is formed from the laminated structure can alsobe included. The instructions 604 can include directions for performingany and/or all of the steps of a method for creating an adjustablesocket, such as any of the procedures discussed above. In other orfurther embodiments, the instructions 604 may provide directions foraccessing such directions. For example, the instructions may list a webaddress, a mailing address, and/or a telephone number that can be usedto locate instructions for preparing a socket. One or more of theforegoing items can be included in and/or on (e.g., in the case of theinstructions) the packaging 606.

FIG. 16 illustrates an embodiment of another template 700 that can beused in a laminating procedure. The template 700 can serve as a cap toprevent liquid resin from entering the base 312 of the housing 310. Inparticular, with reference again to FIG. 14A, in some procedures, thebase 312 and the template 700 can be joined together and can take theplace of the template 400. Accordingly, the base 312 is laminateddirectly in place. The template 700 can include a protrusion 760 thatextends into and fills the base 312. The template 700 can also include aflexible arm 734 and tab 736 that resemble the arm 334 and the tab 336described above. As can be appreciated from the foregoing, other stagesof procedures for using the template 700 in the creation of a wallstructure can proceed in manners similar to or the same as those shownand discussed with respect to FIGS. 14B-14E (where the coupled base 312and template 700 take the place of the template 400), and FIGS. 14G-14J.With particular reference to FIG. G, it can be appreciated that removalof the template 700 creates a void within the laminated structure, whichvoid corresponds with the interior cavity of the base 312.

FIG. 17 illustrates another embodiment of a kit 800 that includesmaterials that can be used in a lamination procedure, such as thosedescribed above. The kit 800 can include any suitable combination of theratcheting device 300, the template 700, an adhesive 802 which can beused in placement of the base 312, a tensioning line 304, a guide 805,and instructions 804, any or all of which can be contained in packaging806. The illustrated ratcheting device 300 is a more heavy duty device.It includes a larger opening 360 and can be used with a differenttensioning line 304 that may be wider and/or stronger. The tensioningline 304 may be a flexible material or cord that can benefit from astiff threading wire 811 for threading through the guide 805. Thethreading wire 811 can be attached to the tensioning line 304 via anysuitable connection 813. After threading of the tensioning line 304, thethreading wire 811 and the connection 813 can be cut from the tensioningline 304.

Additional embodiments of adjustable prosthetic systems are discussedhereafter. In one example, a rotatable ratchet-type device is used inconjunction with a lace or cable member. The lace or cable memberextends around a periphery, or at least a portion of a periphery, of thesocket and is retained in place by a plurality of guide members.Rotation of the ratchet member collects a portion of the lace or cablemember and applies tension in the lace or cable member that results inapplication of a compressive force to the socket and/or the patient'slimb. In at least one example, the compressive forces are applied in thefront-to-back direction (i.e., in either or both of the anterior andposterior directions). Application of such forces can reduce thedistance between the anterior and posterior portions of the socket,thereby tightening those portions of the socket against the patient'slimb to reduce a gap between the patient's limb and the socket thatotherwise is present due to, for example, shrinkage of the limb duringthe course of a day.

In many prosthetic applications, in particular in transfemoral andtranstibial prosthesis, maintaining contact between the residuum and thesocket in the front-to-back direction has a greater impact on stabilityand comfort for the prosthesis as compared to such contact in thelateral (i.e., side-to-side) direction. In at least some arrangements,certain example adjustment systems and methods emphasize adjustabilityof the socket fit relative to the residuum in the front-to-backdirection. In at least some examples, the adjustment systems and methodsare configured to adjust the socket fit in the side-to-side direction.

Typically, a majority of the volume loss in a transtibial residuum is inthe soft tissue, which primarily is composed of the gastrocnemiusmuscle. The gastrocnemius muscle is arranged mostly along the posteriorportion of the residuum, thus making adjusting in the front-to-backdirection sometimes of primary concern as compared to adjustment in theside-to-side direction. However, side-to-side adjustment can also beimportant to stabilize the knee joint and the bony portions (e.g., tibiaand fibula bones) of the residuum.

In some example configurations, adjustment systems may be mounted to anexterior surface of the socket portion of a prosthesis. In otherarrangements, at least portions of the adjustment system areincorporated integral within a portion of the socket, such as, forexample, within a layer or subset below an outer, exterior surface ofthe socket. The socket may comprise a plurality of layers that eachprovide a separate function. For example, a portion of the adjustmentsystems, such as, a lace or cable member, may be positioned betweenlayers of the socket and extend within and move relative to a pathwaydefined between the layers.

Although numbering of the drawings associated with the following text,while internally consistent, varies from that set forth in the foregoingdisclosure, it should be understood that features that are namedsimilarly or identically to the features described above can be similarto or the same as those described above.

FIGS. 18-23 illustrate another embodiment of an adjustable prostheticsystem 900. The system 900 includes a prosthetic device 912, one or moretensioning lines 914, a plurality of guide members 918 a-918 g, and atightening mechanism 916. The prosthetic device 912 includes a socket920, a support or pylon 922, and an ankle-foot structure 924. The socket920 defines a cavity 928 having an upper opening 930 that providesaccess to the cavity 928. The socket 920 also includes a supportattachment 932 to which the support or pylon 922 is mounted. The socket920 includes anterior and posterior portions or sides 934, 936, andlateral and medial portions or sides 938, 940. The cavity 928 isaccessible at an upper end of the socket 920, and the support attachment932 is positioned at a lower end thereof.

The tightening mechanism 916 includes a base 950 and a knob 952.Portions of the tensioning line 914 extend into the tightening mechanism916. The tightening mechanism 916 is configured to collect portions ofthe tensioning line 914 within the tightening mechanism 916. In certainembodiments, rotation of the knob 952 draws the tensioning line 914 intothe tightening mechanism 916 so as to wrap the tensioning line 914 abouta spool member. For example, the tightening mechanism 916 can operate ina manner such as the ratcheting device 300 discussed above.

The tightening mechanism 916 is positioned along the posterior portion936 of the socket 920. In certain embodiments, positioning thetightening mechanism 916 at this location can be advantageous for tryingto conceal the tightening mechanism and positioning it at a locationthat is away from obstacles or other contact during normal use of theprosthetic device 912. Many other locations are possible for thetightening mechanism 916, such as, for example, any location along theother sides 934, 938, 940 and/or at any desired vertical or peripheralposition.

A guide member 918 a is positioned at the anterior portion 934 of thesocket 920. First and second posterior guide members 918 b, 918 c arepositioned along the posterior portion 936 of the socket 920 atpositions that are vertically spaced from each other. Guide members 918d, 918 e that are positioned on the opposing lateral and medial portions938, 940, respectively, and are not configured to substantially change adirection of the tensioning line 914. Additional guide members 918 f,918 g are also positioned on the lateral and medial portions 938, 940,and are configured to change a direction of the tensioning line 914. Theguide members 918 d, 918 e are spaced vertically from the guide members918 f, 918 g, and are slightly forward thereof.

The system 900 can apply a compressive force to the socket 920 atnumerous locations. For example, compressive force can be applied at oneor more positions along the posterior portion 936 of the socket 920. Inparticular, compression may arise at the position where the tensioningline 914 passes through the guide members 918 b, 918 c. The system 900may also apply compressive force along the anterior portion 934 of thesocket 920 at a position where the tensioning line 914 passes throughthe guide member 918 a. Compressive forces may also be applied to thesocket 920 at locations where the tensioning line 914 passes through anyof the guide members 918 d-918 g, although these compressive forces maynot effect as great a change of a configuration of the socket 920.

Various configurations of the guide members may be used in managingmovement of the tensioning member 914 about an exterior of the socket920. For example, the guide member 918 a can maintain the tensioningline 914 in a crossed configuration. Accordingly, a single guide member918 a may be used to cross the tensioning line 914 at a single location.The guide members 918 f, 918 g are configured to change a direction ofthe tensioning line 914. For example, in the illustrated embodiment, theguide members 918 f, 918 g change a direction of the tensioning line 914by approximately 180 degrees. Any of the guide members 918 a-918 g maybe mounted directly to an exterior of the socket 920 using, for example,fasteners, such as rivets or screws. In other embodiments, the guidemembers 918 a-918 g may be formed into a layer of the socket 920 such asin the embodiment shown in FIGS. 24 and 25.

In some embodiments, the socket 920 comprises a laminated material(e.g., is formed via a lamination process). In other embodiments, thesocket 920 comprises a vacuum-formed plastic. In either case, the guidemembers 918 a-918 g, or at least portions thereof, may be attached tothe socket 920 during the formation of the socket 920 or subsequentthereto. For example, in some instances, the guide members 918 a-918 gcan be attached after formation of the socket 920, and may be used toretrofit the socket 920. The tightening mechanism 916, or at least aportion thereof, likewise can be attached to the socket 920 duringformation of the socket or at a time thereafter.

FIGS. 22 and 23 illustrate a manner in which tightening of thetensioning line 914 with the tightening mechanism 916 may alter aninterior shape of the socket 920. FIG. 22 illustrates the socket 920 ina rest state having a lateral width W1 and a length L1. Referring toFIG. 23, radially inward directed forces F1, F2 are applied at theanterior and posterior sides 934, 936, respectively, by tightening thetightening mechanism 916 to apply tension force in the tensioning line914. This application of forces F1, F2 compresses the anterior andposterior sides 934, 936 toward each other to provide a length L2 thatis less than the length of L1. A width W2 typically remains the same ordecreases relative to the width W1 at the rest state shown in FIG. 22.

In the illustrated embodiment, the anterior portion of the socket 920may be viewed as a receptacle that is sized to receive at least aportion of a residuum, and the posterior side 936 of the socket 920 maybe viewed as a movable panel. As shown in FIG. 18, the anterior andposterior portions of the socket 920 can be integrally attached to eachother, and a lower end of the socket 920 thus can act as a hinge aboutwhich the posterior portion can rotate relative to the anterior portion.

Referring now to FIGS. 24 and 25, a prosthetic adjustment system 1000 isshown and described. The prosthetic adjustment system 1000 includes aprosthetic device 1012, a tensioning line 1014, and a tighteningmechanism 1016. The prosthetic device 1012 includes a socket 1020 havingan upper opening 1030, anterior and posterior portions 1034, 1036, andlateral and medial portions 1038, 1040. The socket 1020 is defined by aninner layer 1046 and an outer layer 1048. The outer layer 1048 maycomprise a different material than the inner layer 1046. The outer layer1048 may extend around only a portion of the periphery of the socket1020. For example, a portion of the outer layer 1048 may be positionedalong the posterior portion 1036, and a gap may be provided betweenportions of the outer layer 1048 and certain areas at various positionsabout the periphery of the socket 1020.

In at least one embodiment, a guide path 1019 is defined within theouter layer 1048. Alternatively, the guide path 1019 may be definedbetween the outer layer 1048 and the inner layer 1046. The guide path1019 may have a shape similar to that defined by guide members 918 a-918g described above, and it can operate in a similar manner thereto. Theguide path 1019 may comprise a channel through the material from whichthe outer layer 1048 is formed. The channel may be defined by thematerial itself or by another member that is embedded within thematerial, such as a tube.

The outer layer 1048 may have different physical characteristics thanthe inner layer 1046, such as, for example, a greater stiffness. Theouter layer 1048 may provide additional characteristics that are optimalfor certain areas along the socket 1020 to improve performance and/orcomfort for the user. The outer layer 1048 may also be referred to as ashell.

FIG. 26 illustrates another embodiment of prosthetic adjustment system1100. The prosthetic adjustment system 1100 includes a plurality oftightening mechanisms 1116, 1117 and tensioning lines 1114, 1115. Thetightening mechanism 1116 is positioned vertically above the tighteningmechanism 1117 and the tensioning line 1114 is positioned verticallyabove the tensioning line 1115. In particular, the upper and lowertensioning lines 1114, 1115 define paths that are vertically separatedfrom each other and do not cross. In other examples, at least one of thetensioning lines 1114, 1115 at least partially overlap or bypass eachother in the vertical direction. The socket 1120 may include an upperopening 1130 as well as anterior, posterior, lateral and medialportions.

The tightening mechanism 1116 in combination with the tensioning line1114 and the tightening mechanism 1117 in combination with tensioningline 1115 can each provide a separate compression point or region on asocket 1120. In one example, the compression regions are along aposterior portion 1136 at the location of guide members 1118 b, 1118 d.More generally, a compression region may include both of the guidemembers 1118 b, 1118 d. In other arrangements, compression points may beprovided at any of the guide members 1118 a-1118 f. It is noted that thepositions of the guide members 1118 a-1118 f in the illustratedembodiment are similar to the positions of the guide members 918 a-918 fdescribed above. In some embodiments, a compression region may have athinner wall so as to be more flexible than surrounding regions of thesocket 1120. In other or further embodiments, the compression region maybe comprised of a different material than the surrounding portions ofthe socket 1120.

FIGS. 27-29 illustrate another embodiment of an adjustable prostheticsystem 1200. The prosthetic adjustment system 1200 includes a prostheticdevice 1212, at least two tensioning lines 1214, 1215 (e.g., lace orstrap members), and associated tightening mechanisms 1216, 1217. Theprosthetic device 1212 includes a socket 1220 that defines a cavity 1228that is accessible through an upper opening 1230. The socket 1220includes anterior, posterior, lateral and medial portions 1234, 1236,1238, 1240, respectively.

The tightening mechanisms 1216, 1217 are spaced vertically from eachother. The tightening mechanisms 1216, 1217, in conjunction with thetensioning lines 1214, 1215, provide application of an adjustment ortightening force to the socket 1220. The tightening mechanisms 1216,1217 may be a buckle-type mechanism. The buckle mechanism may beoperable between a released position and a locked position. When in thereleased position the tensioning lines 1214, 1215 are able to moverelative to the tightening mechanisms 1216, 1217, and when in the lockedposition the tensioning lines 1214, 1215 are in a fixed position. Thetightening mechanisms 1216, 1217 may comprise a cam-type or lever-typemember that apply a tension force in the tensioning lines 1214, 1215when the tightening mechanisms are activated between the released andlocked states.

In the embodiment shown in FIGS. 27-29, the tensioning lines 1214, 1215extend fully about a periphery of the socket 1220, and thus may beconfigured to generally apply compressive pressure about the fullperiphery of the socket 1220. In other embodiments, the tensioning lines1214, 1215 can pass through guides such as those discussed above, andthe guides may be sized, positioned, or otherwise configured so as toapply pressure only at desired positions about the periphery of thesocket 1220.

In other embodiments, the tensioning lines 1214, 1215 can extend aboutthe full periphery of the socket 1220, as shown. However, rather thandefining a substantially continuous periphery, such as that shown inFIGS. 27-29, the socket 1220 may have gaps that can be narrowed orclosed upon application of the pressure. Such an arrangement can besimilar to that depicted in FIGS. 18-21. In still other embodiments, thesocket 1220 may have pressure members or panels that can extendoutwardly relative to neighboring portions of the socket 1220. Such anarrangement can resemble that of the panels 122 c, 122 d in FIG. 1. Atensioning line 1215 can encircle the panels 122 c, 122 d. When thepanels 122 c, 122 d are pushed outwardly due to the presence of aresiduum within the socket 1220, the tensioning line 1215 can define aperipheral length. Tightening tensioning line 1215 via the tighteningmechanism 1217 can reduce the peripheral length of the tensioning line1215, which can force the panels 122 c, 122 d about which it extends tosimultaneously be moved inwardly.

In still other embodiments, the tensioning lines 1214, 1215 andtightening mechanisms 1216, 1217 can be more localized. For example,where the socket 1220 includes panels 122 c, 122 d, such as those shownin FIG. 1, the tensioning line 1214 and tightening mechanism 1216 can beassociated only with the panel 122 c, and the tensioning line 1215 andtightening mechanism 1217 can be associated only with the panel 122 d.Specifically, the tensioning line 1214 may be anchored to the socket1220 at a position that is left of the panel 122 c, can extend about anouter surface of the panel 122 c, and can be connected to the tighteningmechanism 1216 at a position that is right of the panel 122 c.Similarly, the tensioning line 1215 may be anchored to the socket 1220at a position that is to the right of the tightening mechanism 1216 andthat is left of the panel 122 d, can extend about an outer surface ofthe panel 122 d, and can be connected to the tightening mechanism 1217at a position that is right of the panel 122 d. When the panels 122 c,122 d extend outwardly from the portions of the socket 1220 thatneighbor each panel, tightening of the tensioning lines 1214,1215 canforce the panels 122 c, 122 d inwardly toward an interior of the socket1220. The tensioning lines 1214, 1215 can be adjusted separately, orindividually so as to move the panels 122 c, 122 d by different amounts,if desired.

The tightening mechanisms 1216, 1217 (as well as the other tighteningmechanisms disclosed herein), which also may be referred to as lockingmechanisms, may include any suitable tightening, locking, and/orsecuring mechanisms, such as any of those discussed above. Theillustrated embodiment shows tightening or locking mechanisms such asbuckles, latches, snaps, hook and loop fasteners, or the like. Furthersuitable tightening mechanisms are disclosed in U.S. Patent ApplicationPublication No. 2008/0066272, which is incorporated herein in itsentirety by this reference. U.S. Pat. No. 7,431,738 discloses additionaladjustable buckles, latches, and associated strap members that can beused as the tightening mechanisms and tensioning lines disclosed herein.U.S. Pat. No. 7,431,738 is also incorporated herein in its entirety bythis reference. Additional examples of suitable devices and systemsinclude various embodiments of a cam assembly that advances or retractsa strap (e.g., a tensioning line), such as disclosed in U.S. PatentApplication Publication No. 2009/0184189, which is incorporated hereinin its entirety by this reference. Suitable tightening mechanisms arealso disclosed in U.S. Pat. No. 7,293,373 and U.S. Patent ApplicationPublication No. 2010/0139057, each of which is also incorporated hereinin its entirety by this reference. The tightening mechanisms can includeratcheting systems such as discussed above, as well as those disclosedin U.S. Pat. No. 6,289,588, the entire contents of which are herebyincorporated by reference herein. Many other incremental tighteningmechanisms having dialing and/or incremental tightening systems areavailable from Boa Technology of Denver, Colo. Where the tighteningmechanism includes an actuator (e.g., the actuator 170 of the tighteningmechanism 108), the actuator can comprise any suitable actuationinterface, such as a knob, lever, button, etc. In various embodiments,the actuator can be actuated in any suitable manner, such as forexample, by any suitable movement (e.g., rotation, pushing, pulling, orsliding). It is also noted that the term “tightening” as used hereinwith respect to the tightening mechanism can refer to the development ofincreased tension in a tensioning line and/or a constriction orreduction of a perimeter defined by the tensioning line such that thetensioning line defines a tighter perimeter. The tightening mechanismmay also be referred to as an adjustment mechansim.

In various embodiments disclosed herein, adjustment of the tighteningmechanism may change an internal size or shape of the cavity of theprosthetic socket. In some embodiments, the adjustment of the size orshape of the internal cavity of the socket may be changed along only aportion of the socket rather than along an entire length of the socket.

Certain tensioning lines disclosed herein may be constructed as anelongate member having any desired cross-sectional shape, such as, forexample, circular, oval, rectangular or triangular cross-sectionalshape. The tensioning lines may be constructed as a strap member havinga greater width than thickness. The tensioning lines may comprise anydesired construction or feature that enhances operability and interfacewith the tightening mechanism. For example, at least a portion of thetensioning line may include a plurality of holes, grooves, protrusionsand may have varying widths and thicknesses. In at least some of theembodiments disclosed herein, a single tensioning line may be used witha plurality of tightening mechanisms. Further, a single tighteningmechanism can be used with a plurality of tensioning lines. A tensioningline may extend along a guide path, wherein the guide path is definedalong any portion of the prosthetic socket. Further, the tighteningmechanism can be positioned at any location on the socket, and in someinstances in other locations on a prosthetic device, such as at asupport pylon (e.g. the pylon 922 in FIG. 18).

FIGS. 30-34 illustrate another embodiment of an adjustable prostheticsystem 1300. The prosthetic adjustment system 1300 includes a prostheticdevice 1312, a pair of tensioning lines 1314, 1315, and a pair oftightening mechanisms 1316, 1317 associated with the tensioning lines1314, 1315, respectively. The prosthetic adjustment system 1300 furtherincludes a plurality of tensioning pads 1318 a-1318 h. The tensioningpads 1318 a-1318 h are arranged to apply a compressive force against auser's limb when tension is applied to the tensioning lines 1314, 1315by the tightening mechanisms 1316, 1317. The tensioning pads 1318 a-1318h can resemble the panels described above (e.g., the panels 122 a-122f), and may also be referred to as compression members or pressuremembers.

The prosthetic device 1312 includes a socket 1320 that defines a cavity1328 having an upper opening 1330. The socket 1320 also includesanterior and posterior portions 1334, 1336, and lateral and medialportions 1338, 1340. Socket 1320 also includes an inner layer or liner1346 and an outer layer or shell 1348.

With reference to FIG. 30A, the shell 1348 can have a general thicknessT2. A padding layer 1321 may be connected or coupled to the shellportion of the tensioning pads 1318 a-1318 h that causes the pads tohave a total thickness T1, which can be greater than the thickness T2 ofthe surrounding region of the shell 1348. Consequently, the tensioningpads 1318 a-1318 h can be forced outwardly relative to the socket 1320when a residuum is positioned therein. Applying a tension force in atensioning lines 1314, 1315 urges the tensioning pads 1318 a-1318 hradially inward to apply a force F to the user's limb in the area of thetensioning pads 1318 a-1318 h.

In the illustrated embodiment, the padding layer 1321 is providedbetween the shall 1348 and the liner 1346 such that the liner iscontinuous in the region of the pads 1318 a-1318 h. In other or furtherembodiments, a padding layer 1321 may be applied to an inner and/orouter surface of the liner 1346, which can similarly force the shellportion of the tensioning pads 1318 a-1318 h outwardly when a residuumis within the socket 1320.

A tensioning pad 1318 may be completely disconnected from the outershell 1348, as shown, for example, by the tensioning pads 1318 a-1318 cin FIG. 30. In other instances, at least a portion of a tensioning pad1318 may be connected to or be integral with at least a portion of theouter shell 1348, as shown, for example, by the tensioning pads 1318d-1818 h in FIGS. 31-33. Typically, at least a portion of eachtensioning pad 1318 a-1318 h is moveable relative to the remainingportions of the outer shell 1348 in a radial direction.

The tensioning pads 1318 a-1318 h may be arranged at any location aroundthe periphery on the prosthetic 1312 and have any shape, size, or numberof placements to provide the desired application of force to the user'slimb. The size and shape as well as the orientation of each of each ofthe tensioning pads 1318 a-1318 h relative to the user's limb may servea different purpose in providing the particular amount and direction offorce at the interface of a given anatomical feature.

Referring to FIGS. 35 and 36 (FIG. 35 showing a left leg having featuresthat are a mirror image of those features shown in the right leg of FIG.36), the tensioning pads 1318 a-1318 h are described for the prostheticadjustment system 1300 shown in FIGS. 30-34. Tensioning pad 1318 a maybe referred to as an interior patellar panel or tensioning pad. Thetensioning pad 1318 a is arranged to apply pressure to a patellar tendon1362. The tensioning pad 1318 a may also be arranged to apply pressureto an infrapatellar panel or pad 1360 (see FIG. 38). The tensioning pad1318 b may be referred to as an anterior lateral panel or tensioningpad. The tensioning pad 1318 b may be arranged to apply pressure on atibialis muscle 1382. The tensioning pad 1318 b may also be arranged toapply pressure on a extensor muscle 1380. In at least some arrangements,the tensioning pad 1318 b may be arranged to ultimately apply pressureon an interosseous membrane 1372 that extends between a fibula bone 1368and a tibia bone 1370.

The tensioning pad 1318 c may be referred to as an anterior medial panelor tensioning pad. The tensioning pad 1318 c may be arranged to applypressure on a medial aspect 1378 of the tibia bone 1370. The tensioningpads 1318 d and 1318 f may be referred to as lateral posterior panels ortensioning pads. The tensioning pads 1318 d, 1318 f may be arranged andconfigured to apply pressure on a gastrocnemius muscle 1364. Thetensioning pads 1318 d, 1318 f may also be arranged and configured toapply pressure on a soleus muscle 1366 as well as a fibularis longusmuscle 1374 and a fibularis brevis muscle 1376.

Tensioning pads 1318 e, 1318 g may be referred to as posterior medialpanels or tensioning pads. The tensioning pads 1318 e, 1318 g may bearranged to apply pressure on the gastrocnemius and soleus muscles 1364,1366. A tensioning panel 1318 h may be referred to as a posterior panelor tensioning pad that is arranged to apply pressure on thegastrocnemius and soleus muscles 1364, 1366.

In at least some arrangements, all of the tensioning pads 1318 a-1318 hare interconnected with a single tensioning line that has tensionadjusted in the tensioning line by a single tightening mechanism. Inother arrangements, such as the one shown in FIGS. 13 17, the tensioningpads 1318 a-1318 h are divided into separate groups of tensioning padsthat are interconnected with separate tensioning lines 1314, 1315. Thetensioning lines 1314, 1315 are adjusted in tension using separatetightening mechanisms 1316, 1317, respectively. In still furtherarrangements, more than two tensioning lines and more than twotightening mechanisms may be used to apply force to the tensioning pads1318 a-1318 h to create radially inward directed forces upon the user'slimb.

Separating the various tensioning pads 1318 a-1318 h into differentzones (i.e., upper, lower, medial and lateral zones) and providingseparate tightening mechanisms for each zone may enhance the user'sability to adjust the amount of tightening or “locking in” at differentregions in the interface between the prosthetic adjustment system 1300and the user's limb. The prosthetic adjustment system 1300 may provideboth enhanced adjustability as to the amount of incremental adjustment,as well as increased flexability in the location in which a tighteningor radially inward directed forces are applied relative to the user'slimb.

The tensioning pads 1318 a-1318 h may be constructed as separate piecesthat comprise a unique material composition, thickness, shape and sizedistinct from any features of the prosthetic 1312. In otherarrangements, at least some of the tensioning pads 1318 a-1318 h areformed from portions of the prosthetic 1312 such as, for example, fromportions of the outer shell 1348. For example, in some embodiments (suchas described above), the tensioning pads 1318 a-1318 h are cut orotherwise formed at least in part from the outer shell 1348.

In some arrangements, at least some of the tensioning pads 1318 a-1318 hare completely disconnected from the outer shell 1348. In otherarrangements, at least portions of at least some of the tensioning pads1318 a-1318 h are interconnected and integral with the outer shell 1348.Typically, at least a portion of each of the tensioning pads 1318 a-1318h is moveable radially inward and outward relative to the remainingportions of the outer shell 1348. Usually the outer shell 1348 maintainsa generally rigid, fixed shape and size while the tensioning pads 1318a-1318 h are moveable radially inward and outward to adjust a radiallyinward directed force relative to the user's limb. This adjustment andapplication of radially inward directed force by the tensioning pads1318 a-1318 h can resolve or otherwise make up a space or gap that mayexist between the user's limb and an interior surface of the prostheticdevice 1312 caused by, for example, shrinkage of the limb due to waterdistribution over the course of a day, loss of weight, and/or otherreasons.

In some arrangements, at least some of the tensioning pads 1318 a-1318 hare mounted directly to an outer surface of the inner liner 1346. Inother arrangements, portions of the inner liner 1346 are removed in thearea around the tensioning pads 1318 a-1318 h such as, for example, inthe area radially spaced inward from the tensioning pads 1318 a-1318 h.In still further arrangements, the inner liner 1346 is completelyremoved from the prosthetic device 1312 such that the user's limbdirectly contacts the inner surface of the outer shell 1348.

The outer shell 1348 also can provide a relatively rigid base orfoundational structure that resists deformation upon application of thetension force in the tensioning lines 1314, 1315 and provides a stablebase or foundation for the tightening mechanisms. The tensioning linesmay be mounted to an exterior surface of the outer shell 1348 such as,for example, using the attachment arrangement shown with reference toFIGS. 18-23. In other arrangements, the tensioning lines 1314, 1315 maybe at least partially embedded within the outer shell 1348 such asdescribed above with reference to the embodiment of FIGS. 24 and 25. Atensioning line can pass through or otherwise be coupled to one or moreof the tensioning pads 1318 a-1318 h at least once, or in somearrangements, at least twice. In some embodiements, the outer shell 1348comprises a carbon fiber or composite material in the guide path (i.e.,the pathway for the tensioning lines 1314, 1315) within the outer shell1348 as defined by a tubular structure. The tubular structure may remainin place within the outer shell 1348. Alternatively, the tubularstructure may be removable. The tubular structure may comprise amaterial that is resistant to degradation when forming the carbon orcomposition outer shell 1348 such as, for example, Teflon or nylon.

The tightening mechanism 1316, 1317 may comprise a ratchet device,spool, and other features that provide incremental adjustment of tensionin the associated tensioning line 1314, 1315. Many types of tighteningmechanisms are possible, each of which provides a different function orpossible advantage. Some example tightening mechanisms are shown anddescribed above.

While the examples illustrated in FIGS. 30-38 are made primarily totranstibial prosthetic prosthesis, the same principals related toadjustment systems and methods may be equally applicable to other typesof prosthesis, such as above the knee (transfemoral), above the elbow(transhumeral), and below the elbow (transradial).

Referring now to FIGS. 36 and 39-43, another example of prostheticadjustment system 1400 is shown and described. The prosthetic adjustmentsystem 1400 is configured for use with a transfemoral (i.e., above theknee) residuum, and includes a prosthetic device 1412, at least onetensioning line 1414, at least one tightening mechanism 1416, and aplurality of tensioning pads 1418 b-1418 e.

The prosthetic device 1412 includes a socket 1420 defining a cavity 1428and having an upper opening 1430, anterior and posterior portions 1434,1436, and lateral and medial portions 1438, 1440. The prosthetic device1412 may further include an inner liner 1446 and an outer shell 1448.

The tensioning pads 1418 b-1418 e may be arranged around a periphery ofthe prosthetic device 1412 and at any desired vertical position. Thesize, shape, orientation, and number of tensioning pads 1418 b-1418 emay provide any desired amount of pressure and radially inward directedforces on the user's limb so as to adjust for improper interfaces (e.g.,gaps or spaces) between the prosthetic device 1412 and the user's limb,such as may result from varying water retention, etc. In at least somearrangements, the tensioning pads 1418 b-1418 e have a greater thicknessthan a thickness of the outer shell 1448. Consequently, applying atension force in the tensioning lines 1414 passing through thetightening pads 1418 b-1418 e applies an inwardly directed force on theuser's limb.

The tensioning pad 1418 b may be referred to as an anterior lateralpanel or tensioning pad. The tensioning pad 1418 c may be referred to asan anterior medial panel or tensioning pad. The tensioning pad 1418 dmay be referred to as a posterior lateral panel or tensioning pad. Thetensioning pad 1418 e may be referred to as a posterior medial panel ortensioning pad.

Each of the tensioning pads 1418 b-1418 e may be arranged to contact agiven feature or combination of features of the user's limb. The user'supper leg may include a femur 1486, a vastus lateralis 1488, a vastusmedialis 1490, a vastus intemdius 1492, a biceps femorous 1494, and anadductor magnus 1496 (see FIG. 43). The tensioning pads 1418 b-1418 emay be arranged to contact any one or combination of these anatomicalfeatures of the user's upper leg.

Each of the tensioning pads 1418 b-1418 e may be completely disconnectedfrom surrounding portions of the outer shell 1448, and may be referredto as free floating pads or panels. In other arrangements, at least someof the tensioning pads 1418 b-1418 e may be connected to the outer shell448, such as being integrally formed and continuous with the outer shell448.

A single tensioning line 1414 and tiny mechanism 1416 are shown anddescribed with reference to the embodiment of FIGS. 39-42 to move thetensioning pads 1418 b-1418 e. The tightening mechanism 1416 is shownpositioned near the upper opening 1430 along the lateral portion 1440 ofthe prosthetic device 1412. This position and location for thetightening mechanism 1416 may promote easier access by the user and may,in some circumstances, be positioned to provide less obstruction ordamage by inadvertent contact. The tightening mechanism 1416 may bepositioned at any location on the prosthetic device 1412.

In other arrangements, multiple tightening mechanisms and multipletensioning lines may be used to apply the desired forces to tensioningpads 1418 b-1418 e. The tensioning pads 1418 b-1418 e may be separatedinto different zones, such as, for example, upper or lower zones,anterior, posterior, lateral, or medial zones, wherein one or more ofthe zones are associated with a single tightening mechanism and singletensioning line. Providing multiple zones and multiple tighteningmechanisms may improve the flexibility available to the user forincrementally and specifically adjusting and tightening the inwardlydirected forces on the user's limb via the tensioning pads 1418 b-1418e.

As with the other embodiments disclosed herein, the tensioning line 1414may be positioned at least partially on an exterior surface of the outershell 1448 and/or embedded within the outer shell 1448. Further, theinner liner 1446 may be completely or partially removed at variouslocations as described with reference to the other embodiments above.

The various prosthetic adjustment system features and functionsdescribed herein can reduce the amount of soft tissue interface betweenthe user's limb and the prosthetic device. In some arrangements, theprosthetic adjustment system tends to more completely and solidly engagewith the bony portions of the user's limb, such as along the length ofthe bone shaft, whether solid or semi-solid portion of the user's limb.

Referring now to FIG. 27, an example kit 1500 is shown comprisingcertain components for creating a prosthetic adjustment system. The kit1500 includes a package 1501 within which is included a plurality oftensioning lines 1514 b, 1514 b, a plurality of tightening mechanisms1516 a, 1516 b, a plurality of guide members 1518 a, 1518 b (e.g.,constructed as bracket members) and 1518 c, 1518 d (e.g., constructed asconduit or tube members), and a plurality of tensioning members 1519 a,1519 b. The tightening mechanisms 1516 a, 1516 b include a base 1550, aratchet member 1552, a spool 1554, and a turning knob 1556. Thetensioning lines 1514 a, 1514 b are collected on the spool 1554 uponrotation of the ratchet member 1552.

The kit 1500 may be used either for retrofitting an existing socket 1520or for creating a new socket. For example, the bracket-like guidemembers 1518 a, 1518 b may be used with an existing socket 1520 and maybe mounted to an exterior of the socket 1520. In some instances, one ormore moveable panels may be cut in the socket 1520, and one or moreguide members 1518 a can be mounted to each of the panels. One or moreadditional guide members 1518 b can be mounted to a remaining receptacleportion of the socket 1520, and a tensioning line 1514 a can be strungthrough the guide members 1518 a, 1518 b and connected with thetightening mechanism 1516 a. In use, the modified socket 1520 can allowfor adjustment of the newly created panel relative to the receptacleportion of the socket. In some instances it can be desirable to addpadding to an interior of the newly created panels. Accordingly, in someinstances, the kit 1500 can include padding that can be applied at aninterior of the newly formed panels. In some embodiments, the kit 1500can include mounting hardware, adhesives, and or attachment devices ofany suitable variety by which the guide members 1518 a, 1518 b and/or bywhich the padding may be attached to the panels.

The guide members 1518 c, 1518 d of the tube variety may be used, forexample, in the creation of a new socket, such as in methods discussedabove. Further embodiments of the kit 1500 may be directed primarily toone use or another, whether for retrofitting or for original manufactureof a socket. Accordingly, various kits may have more or fewer items thanthose depicted in the illustrated embodiment. Moreover, in someembodiments, the kit 1500 can include instructions, such as thosediscussed above. The instructions can provide information regarding anysuitable method for constructing an adjustable prosthetic system.

In various embodiments, the kit 1500 may include a dummy 1560, 1562 foruse in formation of a socket. In some instances, a dummy may be used ina vacuum forming technique. In other instances, a dummy may be used in alamination technique. In one example, a lamination dummy is constructedas a lid to seal off the inner portions of the tightening mechanism 1516a, 1516 b to protect them during the lamination process. A flange orskirt portion 1551 of the base 1550 of the tightening mechanism 1516 a,1516 b may laminated between layers in the socket 1520. In one example,the flange portion 1551 is extends radially outward about 0.25 inches toabout 0.375 inches from the base 1550. The flange portion 1551 can belaminated directly between layers of a wall structure of the socket.

In other embodiments, the flange portion 1551 of the base 1550 mayfunction as a stop lip on vacuum formed socket. The flange portion 1551can permit increased tension applied on an outer surface of the socketwithout pulling the tightening mechanism 616 a, 616 b out of the socket.

The ratchet member 1552, spool 1554 and knob 1556 may be removed beforelaminating and replaced with a positive dummy 1560 to seal closed thetightening mechanism 1516 a, 1516 b so as not to fill with resin duringlamination. Thereafter, the top of the dummy 1560 is ground down andremoved, and the ratchet member 1552, spool 1554 and knob 1556 areassembled on the base 1550, and further forming steps can be performed.

In another example, a vacuum forming dummy 1562 may be used in place ofthe tightening mechanism 1516 a, 1516 b to help form an aperture in thesocket. The dummy 1562 may comprise, for example, Delron or similarpolymeric material. The dummy 1562 may comprise the same profile (e.g.,circumference and/or diameter) as the tightening mechanism 1516 a, 1516b. In one arrangement, the dummy 1562 has a height H of about 0.25inches to about 1 inches, and in some embodiments, can be about 0.375inches. The dummy may be placed on the patient mold (i.e., the moldrepresenting the patient's residuum) before vacuum forming. After vacuumforming, the portion of the socket covering the dummy can be grounddown, and the dummy can then be removed. When the dummy is removed fromthe socket, an aperture remains that is sized for insertion of thetightening mechanism 1516 a, 1516 b.

The example adjustment systems disclosed herein may be particularlyuseful for applying a compressive force to a socket portion of aprosthetic at a single location, such as, for example, an anteriorpatellar tendon bar or a posterior gastrocnemius location. There may beadvantages of some of the example adjustment systems and methodsdisclosed herein related to application of a compressive force to thesocket at two or more locations. There may be advantages related toapplication of a compressive force at three or more locations by theexample adjustment systems and methods disclosed herein. The ability tocustomize the example adjustment systems disclosed herein forapplication of compressive forces at certain locations on a socket canbe desirable in many instances.

The particular location of the compressive force applied by, forexample, increasing tension in a tensioning line using a tighteningmechanism having incremental adjustment capabilities can be anadvantageous property of certain embodiments disclosed herein. Anotheradvantage may relate to adjusting an internal dimension of a socketcavity of a prosthetic device using floating panels or other structurethat is movable relative to a rigid portion of the cavity.

Certain principles that are described above with reference to lower limbprosthetic adjustment systems could also be applied to upper limbprosthetic adjustment systems such as those systems needed for above andbelow the elbow. Further, while wire tensioning systems have beendiscussed, other tensioning systems may be applicable. For example, airor other fluid bladders may be used, alone or in combination with thewire tensioning systems disclosed herein, along an inner surface of aprosthetic device to apply the desired amount of pressure and/or fillspace between the patient's limb and the prosthetic device.

As is apparent from the foregoing disclosure, in some embodiments, aprosthetic adjustment system includes a socket member, at least onetensioning member, at least one tensioning line, and at least onetightening mechanism. The socket member defines a cavity sized toreceive a portion of a human limb, wherein the socket portion has ananterior portion and a posterior portion. The at least one tensioningmember is arranged to move radially inward relative to the socketmember. The at least one tensioning line is connected to the tensioningmember. The at least one tightening mechanism is positioned on thesocket portion and configured to adjust tension in the tensioning lineto move the tensioning member relative to the socket.

In various embodiments, the socket has a single piece structure that isform-fit to the shape and size of the residuum. In other embodiments,the socket can include multiple pieces, such as a double piece structurewith a flexible inner interface and rigid exterior socket. In at leastsome examples, the socket is generally continuous around itscircumference and from the top to bottom of the socket. In otherexamples, the socket is discontinuous around its periphery at somelocations along a length of the socket. The socket may include aplurality of openings, cut out portions, and flexible or cantileveredportions that assist in tightening the socket about the limb.

In some embodiments, a prosthetic adjustment kit can be configured foruse with an existing prosthetic socket and/or in the formation of a newsocket. Some kits may include a package, at least one mechanicaltightening mechanism positioned in the package, at least one tensioningline positioned in the package, and at least one tensioning member. Thetensioning line can ultimately be connected to the tensioning member.Applying tension in the tensioning line with the tightening mechanismmoves the tensioning member relative to the prosthetic socket. The kitmay also include at least one lace or tensioning line guide in thepackage. The lace guide may be used to secure the tensioning line to thesocket and/or tensioning member. The kit may further include at leastone laminating dummy the package for use in forming the socket.

In some embodiments, a method of adjusting a fit between a socketportion of a prosthetic device and a patient's limb can includeproviding a prosthetic adjustment system having at least one tensioningline, wherein at least one tensioning member, and at least onetightening mechanism, at least partially wrapping the at least onetensioning line around the prosthetic device, and adjusting the at leastone tightening mechanism to change tension in the at least onetensioning line. Increasing tension in the at least one tensioning linechanges moves the tensioning member relative to the socket portion ofthe prosthetic device to tighten the socket portion about the person'slimb.

In certain embodiments, a prosthetic device can includes a rigid socketmember defining a cavity sized to receive a portion of a person's limb,and at least one panel member positioned at a location around aperiphery of the socket member. The at least one panel member is movableinto the cavity. The device further includes an adjustment mechanismconfigured to move the at least one panel member relative to the cavityto apply a force to the person's limb positioned in the cavity.

It will be understood by those having skill in the art that changes maybe made to the details of the above-described embodiments withoutdeparting from the underlying principles presented herein. For example,any suitable combination of various embodiments, or the featuresthereof, is contemplated.

Any methods disclosed herein comprise one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

References to approximations are made throughout this specification,such as by use of the terms “about” or “approximately.” For each suchreference, it is to be understood that, in some embodiments, the value,feature, or characteristic may be specified without approximation. Forexample, where qualifiers such as “about,” “substantially,” and“generally” are used, these terms include within their scope thequalified words in the absence of their qualifiers. For example, wherethe term “substantially planar” is recited with respect to a feature, itis understood that in further embodiments, the feature can have aprecisely planar orientation.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure or characteristicdescribed in connection with that embodiment is included in at least oneembodiment. Thus, the quoted phrases, or variations thereof, as recitedthroughout this specification are not necessarily all referring to thesame embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim require morefeatures than those expressly recited in that claim. Rather, as thefollowing claims reflect, inventive aspects lie in a combination offewer than all features of any single foregoing disclosed embodiment.

The claims following this written disclosure are hereby expresslyincorporated into the present written disclosure, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.Moreover, additional embodiments capable of derivation from theindependent and dependent claims that follow are also expresslyincorporated into the present written description. These additionalembodiments are determined by replacing the dependency of a givendependent claim with the phrase “any of the preceding claims up to andincluding claim [x],” where the bracketed term “[x]” is replaced withthe number of the most recently recited independent claim. For example,for the first claim set that begins with independent claim 1, claim 3can depend from either of claims 1 and 2, with these separatedependencies yielding two distinct embodiments; claim 4 can depend fromany one of claim 1, 2, or 3, with these separate dependencies yieldingthree distinct embodiments; claim 5 can depend from any one of claim 1,2, 3, or 4, with these separate dependencies yielding four distinctembodiments; and so on. Similarly, for the second claim set that beginswith independent 15, claim 17 can depend from either of claims 15 and16, with these separate dependencies yielding two distinct embodiments;claim 18 can depend from any one of claim 15, 16, or 17, with theseseparate dependencies yielding three distinct embodiments; claim 19 candepend from any one of claim 15, 16, 17, or 18 with these separatedependencies yielding four distinct embodiments; and so on.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. Elements specifically recited inmeans-plus-function format, if any, are intended to be construed inaccordance with 35 U.S.C. §112 ¶6. Embodiments of the invention in whichan exclusive property or privilege is claimed are defined as follows.

The invention claimed is:
 1. A kit for use in the manufacture of aprosthetic socket, the kit comprising: a tensioning line; a guide sizedto receive the tensioning line therethrough; a tightening mechanismconfigured to be coupled with the tensioning line; and one or more ofinstructions for creating an adjustable prosthetic socket using thetensioning line, the guide, and the tightening mechanism or directionsfor accessing instructions for creating an adjustable prosthetic socketusing the tensioning line, the guide, and the tightening mechanism. 2.The kit of claim 1, wherein the tightening mechanism comprises a basethat defines a perimeter, the kit further comprising a template thatdefines a perimeter that is the same size as or larger than theperimeter of the base.
 3. The kit of claim 2, wherein the instructionsfor creating an adjustable prosthetic socket comprise directions to:advance liquid resin about at least a portion of the template during alamination procedure; remove the template from a laminated structurethat results from setting of the liquid resin so as to provide a voidwithin the laminated structure; and insert at least a portion of thetightening mechanism into the void.
 4. The kit of claim 3, wherein thetemplate comprises a protrusion that is configured to form a recess inthe laminated structure, and wherein the tightening mechanism comprisesa tab that is sized to be received within the recess.
 5. The kit ofclaim 3, wherein the kit further comprises an adhesive that isconfigured to be used to maintain the template in a desired positionduring the lamination procedure.
 6. The kit of claim 1, wherein theinstructions for creating an adjustable prosthetic socket comprisedirections to: advance liquid resin about at least a portion of a guideduring a lamination procedure; permit the liquid resin to set so as toyield a laminated structure; and insert the tensioning line through theguide.
 7. The kit of claim 6, wherein the instructions for creating anadjustable prosthetic socket further comprise directions to cut throughthe laminated structure and the guide so as to form a panel in thelaminated structure, and wherein the directions indicate that the panelshould be formed before the tensioning line is inserted through theguide.
 8. The kit of claim 6, wherein the guide comprises a hollow tube.9. The kit of claim 1, wherein the instructions for creating anadjustable prosthetic socket comprise directions to: attach the guide toan outer surface of a panel of the prosthetic socket; and insert thetensioning line through the guide.
 10. The kit of claim 1, wherein thetightening mechanism comprises a spool, and wherein the instructions forcreating an adjustable prosthetic socket comprise directions to pass thetensioning line through the guide prior to connecting at least one endof the tensioning line to the spool.
 11. The kit of claim 1, wherein thetightening mechanism comprises a spool to which at least one end of thetensioning line can be attached, and wherein the tightening mechanism isconfigured to permit the spool to rotate in a first direction so as towrap the tensioning line about the spool and is configured to preventthe spool from rotating in a second direction.
 12. The kit of claim 1,wherein a single package comprises the tensioning line, the guide, thetightening mechanism, and the one or more of instructions for creatingan adjustable prosthetic socket or the directions for accessinginstructions for creating an adjustable prosthetic socket.
 13. The kitof claim 1, wherein the instructions for creating an adjustableprosthetic socket comprise directions to attach a pad to an interiorsurface of a panel, with the result that the panel and the pad togetherwill define a thickness that is greater than a thickness defines by aportion of the prosthetic socket that is adjacent to the panel.
 14. Thekit of claim 1, further comprising a pad that is configured to beapplied to an inner surface of a panel.
 15. The kit of claim 1, whereinthe tightening mechanism comprises a ratcheting device.
 16. A kit foruse in the manufacture of a prosthetic socket, the kit comprising: atensioning line; a guide sized to receive the tensioning linetherethrough; a tightening mechanism configured to be coupled with thetensioning line, wherein the tightening mechanism comprises a base; anda template that defines a perimeter that is the same size as or largerthan at least a portion of the base, wherein the template is configuredto be encompassed about its perimeter by a resin that is in liquid formduring formation of the prosthetic socket and, after the resin hardens,is configured to be removed from the resin to form a cavity into whichthe base of the tightening mechanism can be received.
 17. The kit ofclaim 16, further comprising one or more of instructions for creating anadjustable prosthetic socket using the tensioning line, the guide, thetightening mechanism, and the template or directions for accessinginstructions for creating an adjustable prosthetic socket using thetensioning line, the guide, the tightening mechanism, and the template.